Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses

Not Applicable

Completed

• Conditions: Habitual Soft Contact Lens Use
• Interventions: Device: kalifilcon A lenses; Device: Dalies Total 1; Device: Precision 1; Device: Biotrue ONEday

• Registration Number: NCT04555031
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, subjects will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-09
• Study First Submitted: 2020-09-11
• Primary Completion: 2020-09-16
• Study Completion: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-18
• Results First Submitted: 2021-08-18
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-08
• Last Update Submitted: 2021-10-08
• Results First Posted: 2021-11-08
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 18 years or older and have full legal capacity to volunteer.
• Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• No active ocular disease or allergic conjunctivitis.
• Not using any topical ocular medications.
• Willing and able to follow instructions.
• Signed a statement of informed consent.

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Exclusion Criteria

• Participating in a conflicting study in the opinion of the Investigator.
• Considered by the Investigator to not be a suitable candidate for participation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
kalifilcon A lenses	kalifilcon A lenses	-
Dailies Total 1	Dalies Total 1	-
Precision 1	Precision 1	-
Biotrue ONEday	Biotrue ONEday	-

Primary Outcome Measures

Name	Time	Method
Surface Refractive Index Shifts at 5 Minutes	5 minutes	Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Surface Refractive Index Shifts at 15 Minutes	15 minutes	Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Surface Refractive Index Shifts at 10 Minutes	10 minutes	Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.

Trial Locations

Locations (1)

Bausch and Lomb Site 01; 🇺🇸 Rochester, New York, United States